A Study of a Live Intranasal Influenza Vaccine in Children With Cancer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Biological: Inactivated influenza vaccine; Biological: FluMist

• Registration Number: NCT00906750
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

Detailed Description

The secondary objectives of this study are to:

1. Describe the safety of FluMist and inactivated influenza vaccine.

2. Describe the incidence and duration of viral replication following immunization with FluMist.

3. To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-21
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study
• Participant or participants parent/legal guardian available by telephone during the course of the study;
• Written informed consent (and assent, if applicable) obtained
• Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
• If the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent;
• Estimated life expectancy of > 1 year

Exclusion Criteria

• History of hypersensitivity to any component of FluMist or TIV, including egg or egg products, gelatin, or monosodium glutamate;
• History of hypersensitivity to gentamicin;
• Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment
• History of Guillain-Barre´ syndrome;
• History of asthma;
• Female who is breastfeeding or lactating;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Inactivated influenza vaccine	-
1	FluMist	-

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer	6 months

Secondary Outcome Measures

Name	Time	Method
Immunization response	10/31/2010	To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).
Flumist safety	2 years	Describe the safety of FluMist and inactivated influenza vaccine.
Viral Replication	1 year	Describe the incidence and duration of viral replication following immunization with FluMist.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States